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Completed

NCT Number: NCT01276444

Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair

Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice.

Several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular permeability is of a great clinical value to control the efficacy of these approaches.

Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163000, Russia

About this study

Forty-three adult patients scheduled for elective two valve replacement/repair were enrolled into randomised single-centre study. All interventions were performed in cardiosurgical department of City hospital #1 (Arkhangelsk, Russian Federation) by the same surgical team. Three patients were excluded from the analysis; two - due to protocol violation and one - due to inadequate surgical correction diagnosed by intraoperative transoesophageal echocardiography.

Day before surgery patients were asked for informed consent and randomized in two groups. In the first group postoperative haemodynamic optimization was targeted on parameters provided by pulmonary artery catheter (the PAC-group, n = 20): pulmonary arterial occlusion pressure, cardiac index (LifeScope monitor, Nihon Kohden, Japan) and hemoglobin blood level. In the second group haemodynamics was managed using parameters given by transpulmonary thermodilution (the COMPLEX-group), that included cardiac index, global end-diastolic volume index, extravascular lung water index, continuous central venous oxygen saturation, and oxygen delivery index as measured with PiCCO2 monitor (Pulsion Medical Systems, Munich, Germany. In addition, mean arterial pressure, heart rate, and hemoglobin concentration were included into both PAC- and PiCCO2-driven protocols.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Two valve repair / replacements
  • Age above 18
  • Informed consent

Exclusion criteria

  • pulmonary hypertension
  • insulin-dependent diabetes mellitus
  • severe atherosclerosis of femoral arteries
  • severe respiratory failure
  • pregnancy

Treatment and study plan

Swan-Ganz catheter

Device

the data s=derived from PAC included pulmonary artery occlusion pressure etc

Other names: Not actual

transpulmonary thermodilution + central venous saturation

Device

Described in details above

Other names: Non actual

Primary outcomes

  1. Mortality

    Time frame: Day 28

    Mortality rate at Day 28

Secondary outcomes

  1. Fit for discharge

    Time frame: non actual

    Formal 'fit for discharge from ICU' criteria

  2. Vasoactive support

    Time frame: 7 days

    Duration of vasopressor and or inotrope support

  3. Duration of respiratory support

    Time frame: Day 7

    The total duration of the respiratory support

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Collaborators

  • University of Tromso

Registry information

Official study title

Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2011
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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